Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma

Johns Hopkins Medicine

Status

Completed

Conditions

Lymphoma

Treatments

Device: Patient-specific dosimetry

Device: conventional dosimetry

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00416312

CDR0000522705 (Registry Identifier)

R01CA116477-01A1 (U.S. NIH Grant/Contract)

J0636

NA_00001712 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab and yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with non-Hodgkin's lymphoma.

Full description

OBJECTIVES:

Primary

Determine the relationship between estimated absorbed dose and tumor response using different dosimetric methodologies in patients with non-Hodgkin's lymphoma treated with iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan.
Determine the relationship between estimated absorbed dose and normal organ toxicity using different dosimetric methodologies in these patients.

Secondary

Assess the difference in the dose-response relationship between dosimetric methodologies in these patients.
Assess the influence of prior therapy on the dose-response relationship for hematologic toxicity in these patients.

OUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I 131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).

Stratum 1: Patients receive dosimetric rituximab IV followed by indium In 111 (^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9.
Stratum 2: Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I tositumomab IV over 20 minutes on approximately day 7.

In both strata, blood is collected at baseline to measure FLT-3 levels. All patients also undergo a baseline PET/CT scan.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.

Enrollment

9 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of non-Hodgkin's lymphoma
Measurable disease by CT scan or nuclear medicine imaging
Eligible, by standard of care criteria, for iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan treatment

PATIENT CHARACTERISTICS:

No other malignancy within the past 3 years except basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
Not pregnant or nursing
Fertile patients must use effective contraception
No alcoholism or drug abuse within the past 2 years
No severe emotional, behavioral, or psychiatric problems that would limit study compliance

PRIOR CONCURRENT THERAPY: